The following data is part of a premarket notification filed by Den-mat Holdings, Llc with the FDA for Tenure4g.
| Device ID | K140537 |
| 510k Number | K140537 |
| Device Name: | TENURE4G |
| Classification | Agent, Tooth Bonding, Resin |
| Applicant | DEN-MAT HOLDINGS, LLC 1017 W Central Ave Lompoc, CA 93436 |
| Contact | Helen Ragus |
| Correspondent | Helen Ragus DEN-MAT HOLDINGS, LLC 1017 W Central Ave Lompoc, CA 93436 |
| Product Code | KLE |
| CFR Regulation Number | 872.3200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-03-04 |
| Decision Date | 2014-08-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D813TEN40000 | K140537 | 000 |
| D8130398140000 | K140537 | 000 |